Steps involved to register the herbal medicine

Query:

This is with regards to the herbal products and registration. I would like to know to steps involved to register the herbal medicine.

Response:

Herbal Medicines and Ayurvedic Medicines are synonyms in Indian Market. Herbal Medicines are manufactured by same way and under same manufacturing license as of Ayurvedic Medicines. Herbal Medicines could be manufactured only with proper manufacturing license issued by AYUSH department.

Two type of registration could be for herbal medicines. One for Registration of herbal medicine for manufacturing and second for its Brand Name/Trade Name registration.

A herbal medicine combination for manufacturing can be registered only by Herbal Medicine Manufacturer having Ayurvedic/Unani/Sidha Medicine manufacturing licence but Brand Name/Trade Name can be registered by its owner i.e. any person/marketed company/manufacturing company

For registering Herbal Medicine for manufacturing, you first need to take Herbal medicine manufacturing license under AYUSH department. Read Procedure to take Herbal medicine license here

Along with applying manufacturing license, you can file herbal medicines or any time after receiving manufacturing license, you can apply for herbal medicine registration.

Some herbal products (not medicines) also manufactured under Food and Dietary supplements under FSSAI license. Herbal Cosmetic Products are manufactured under both type of manufacturing license i.e. ayurvedic manufacturing license and Cosmetic Manufacturing License.

Only BAMS/BUMS doctors are allowed to manufacture herbal medicines for only their own patients without manufacturing license and medicine registration.

Read our detailed article about How to register Ayurvedic and Pharma Product before launching in Market?

Hope above information is helpful to you….

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Meaning of IP/BP/USP | Licenses Required For Selling Over the Counter Products

Query:

We are into Processed Food product business and operating under private our private brand. Now we are looking to foray into OTC-Healthcare segment specifically with Antacids, Pain Relievers Gel/Spray & Vitamin tablet. So going through internet for a query whether Above mentioned products requires any type of wholesale allopathy drug license because we want to develop brand with allopathy formulations. This was the blog we came across and it has mentioned something about IP/BP/USP meaning.

Q1) Now we want to exactly understand what type of Medicines would not require Allopathy Drug License?
Q2) Most of the Pain Relieving Gel/Spray has IP & BP after ingredients,so will we be able to market that with a DL?
If you can please revert us with proper guidance or where can we get proper information regarding the products to be classified as OTC or Pharmaceutical preparation we would be grateful.
Hoping to get revert ASAP.
Response:
  • IP stand For Indian Pharmacopoeia
  • BP stand for British Pharmacopoeia
  • USP stand for United State Pharmacopoeia
These are the reference books that contains standard of particular salt/ingredient used for making a medicine. A medicine label must show ingredient’s reference book standard which is complied by ingredient.  This is also used for differentiating few products that are manufactured in Medicine as well as Food Supplements. Now come to your questions
Q1)Now we want to exactly understand what type of Medicines would not require Allopathy Drug License?

Answer: All type of medicines (whether it is prescription or Over the Counter OTC) require allopathic drug license. No medicine can’t be sell out without drug license.

Q2) Most of the Pain Relieving Gel/Spray has IP & BP after ingredients,so will we be able to market that with a DL?
Ans: All pain relieving gel/spray which has IP/BP after ingredient can’t be sell without drug license. You have to take drug license before proceeding in this matter. Read requirement for wholesale drug license here
Hope above information is useful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Renewal Omitted: No Need for Renewal of Pharmaceutical Drug Licences and its Effect

With effect from new amendment in Drug and Cosmetic Act, 1945, you will not need for renewal of your drug license in future. If you have Retail/Pharmacy, Wholesale/Distribution, Loan or Manufacturing License Form* for pharmaceutical and cosmetic preparations then you will have no need to renew it.

You only need to deposit license retention fee before expiring of a period of every succeeding five years from date of issue of its issue, unless it is suspended or cancelled by licensing authority.

In case Licencee failed to deposit this fees at due time, then licencee shall be liable to pay licence retention fee along with a late fee calculated at the rate of two percent. In case of of non payment till six month, License shall be deemed to have been cancelled.

This amendment will be beneficial for all pharma business correspondents. It was tricky process to renew drug license. One has to follow complete process as in case of new license.

Now this amendment will provide relief to all manufacturing, wholesale and retail licencee whose licence were due this year and in future.

But few rules also been added through this amendment. Now your premises will be inspected by drug inspector at compulsory basis for minimum of one time in three year. Maximum number of inspection could be as needed as per risked based approach.

More rule is added in the provision.

For Retail and Wholesale: – Inspection for verification of compliance:  “The licensing authority shall cause inspection, by the Inspector  appointed under the Act, of each premises licensed under this Part, to verify the compliance with the conditions of licence and the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach.”

For Manufacturing and Loan Licensing:-  Inspection for grant of licence and verification of compliance.-

“(1) Before a licence in Form —–* is granted, the licensing authority shall cause the establishment in which the manufacture of drugs is proposed to be conducted or being conducted to be inspected jointly by the Drugs Inspectors appointed by the Central Government and the State Government under this Act who shall examine the establishment intended to be used or being used for the manufacture of drugs.

(2) The premises licensed under sub-rule (1) shall be inspected jointly by Inspector appointed by the Central Government and State Government to verify the compliance with the conditions of licence and the provisions of the Act and these rules not less than once in three years or as needed as per risk based approach.”

Same rules will also be applicable for manufacturing and loan licensing of cosmetic and Homeopathy products.

Effect of omitting Renewal at Pharmaceutical Sector:

  1. Renewal was a time consuming process. This will prevent time consumed during this process.
  2. It will build transparency in drug license process.
  3. Work Overload of drug department will be less. Now Drug Department can concentrate at proper implementation of laws and rules according to Drug and Cosmetic Act.
  4. Inspection will be compulsory. It will forced licencee to fulfill all requirements as drug department may conduct inspection at regular basis.
  5.  This amendment is focus at implementing good manufacturing standards as new plants will be inspected by Joint team of Center and State Drug Authority.
  6. Quality of Products manufactured in India may improve as manufacturing standard compliance could be regularly checked.
  7. More control of Drug Authorities will be at ground level for maintaining standards and availability of quality products.

* Form:

Form 19, Form 19A, Form 19AA and Form 19C, Forms 20, 20A, 20B, 20BB, 21C, 21CC, 20F, 20G, 21, 21A, 21B or Form 21BB,  Form 24, Form 24A, Form 24B, Form 24C, Form 24F, Form 25 or Form 25A or Form 25B or Form 25F, Form 26, Form 26A, Form 26B, Form 26F, Form 26H, Form 27, Form 27A, Form 27B, Form 27D, Form 27DA, Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA, Form 31 and Form 31A, Form 32 or Form 32A, Form 33, Form 33, Form 33A, Form 37 and Form 38. Know more about form Read our Article: Types of Licences required to start business in Pharmaceutical Sector

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How many years the Schedule H1 Medicines Record To Be Kept Stored

Query:
I have some queries
1. What are the details of a patient and doctors has to be noted and to be keep in record?
If possible please attache specimen sample
2. For How many years the Schedule H1 Medicines Record To Be Kept Stored?
3. Is only purchase bill of schedule h1 drugs is to be maintained/stored or the sale bill of their is also?

Response:

  • Name and address of prescriber with patients name, name of drug, quantity dispensed shall be maintained in a separate register.Check reference/specimen copy by clicking at link of Drug Authority website
  • Record should be kept for 3 years.
  • All sale and purchase record shall be maintained for 3 years

For detail analysis read our article: Schedule H1 drugs and how to maintain record?

Query: 
How to maintain the record of sale of H1 drugs in a hospital pharmacy where these drugs are sold to both in patient and out patient.

Response: 
Maintain a register having detail of doctor against whose prescription medicines are issued and all patients to whom medicines are issued. Record maintenance is compulsory. You can maintain different register for indoor and outdoor patients. Read in detail about Schedule H1 drugs by clicking here

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Do Ayurvedic Products require any license to sell at own Clinic?

Query:
I am a BDS doctor, I want to sell ayurvedic drugs from my clinic do I need any licence or any Pan card etc.. How much investment required for PCD marketing company.

Response:

For selling Ayurvedic Products at your clinic, you will not require any drug license…
Investment to start pcd marketing company depend at number of products you launch

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Related Articles:

Is there any need of Drug License for OTC products supply?

Query:
I saw your pharma blog website. I have gone through details. I have question. I want to start dealing in OTC Products as a supplier in Hospital. I have GST NUmber. I have registered as a proprietor. Some one told me , for OTC Products I don’t need any drug license. May I start dealing in OTC Products on the basis of GST Number? Looking forward to hear from you.

Response:

Drug license is not required for those OTC products which don’t come under medicines/drugs/healthcare/pharma/derma products. If a OTC products is manufactured under pharmaceutical product then you will require to have wholesale drug license to supply these preparations.

In pharma sector, non prescription products are generally considered as OTC products. One of the main thing to identify whether it is pharmaceutical preparation or not. A pharmaceutical preparation composition section always contains I.P., B.P., U.S.P. just after active ingredient. This is most common identity of pharmaceutical preparation even it is not a prescription product (Rx).

Commonly used Over the counter (OTC) products in pharmaceutical sector are:

For selling and supplying pharmaceutical products, you need drug license. For food and dietary supplements, you required FSSAI registration. For Cosmetic and ayurvedic preparations, no drug license is required, only GST is enough.

Hope above information is helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Temperatures and Storage Conditions to be maintained in the Pharmaceutical Establishments

Query:
Myself ———–, a final year student of B.Pharmacy. I would like to setup a Distribution & retail business after I pass out. But unfortunately I have failed to acquire much guide regarding the temperatures that are required to be maintained in both the pharmacy retail shop & wholesale storage warehouse for storing medicines. It would be at my utmost benefit if you can kindly guide me regarding the same. Hope to hear from you soon as always. Awaiting your answer with great anticipation Sir!

Response:

Every pharmaceutical dosage form and ingredients have different storage temperatures. Storage conditions are mostly mentioned at medicines label. Some medicines require conditions like store in cool & dry place below 25*C temperature, few require freezing conditions, few require refrigeration etc. You need to store medicines as per mention at label or packaging. If there is no mention about storage condition then medicines should be store at cool, clean and dry place. For maintaining cool and dry place, air conditioner is best way. Store medicines under air conditioned room if storage condition are not mentioned at medicines.

Hope above information is helpful to you…

How to register new Ayurvedic Formulation before launching in India?

Query:
Reference to your blog http://www.pharmafranchisehelp.com/where-to-register-your-pharmaceutical-ayurvedic-products/, I’d like to know few things related to ayush laws.I am basically going to start my own Ayurvedic manufacturing plant and launch several ayurvedic products. I have few questions related to regulatory part:
I want to formulate a dietary supplement with an imported ingredient, which is not currently in the ayush pharmacopeia, so how should I proceed with product registration/approval?

I have come across two Ayurvedic formulations currently in Indian market with the same imported ingredient I want to use, but I want to prepare different combination with this imported ingredient, can the existing formulations help me in some way for getting approval?
Also, for registration of new combination formulas, what is the procedure? Can you send me any links for procedure?
Do ingredients require approval separately or only formulations require approval?

Response:

1. If it is a Dietary supplement then there is minimum chances, you get approval as Ayurvedic Preparation. Ayurvedic preparations contains ingredients that have some clinical effects as per old Ayurvedic literatures, Ayurvedic Pharmacopeia, pharmacognosy books and other acceptable Ayurvedic references. Dietary supplements and Ayurvedic Preparations are two different things. Dietary supplements can’t claim any medicinal or treatment property where as Ayurvedic Preparations can do in some case. Now situation is unclear, imported ingredient is purely dietary supplements like vitamins or minerals etc or any herb that may have some clinical effects. If you provide any reference related to its clinical property and it is herbal form then you can proceed for approval as Ayurvedic Product.
2. If two Ayurvedic products are already using this ingredient then you can add reference of these products also with your application of your Ayurvedic Formulation with any Ayurvedic book reference if Ayush department show any objection at this ingredient.
3. Every state follow some different norms for approving new Ayurvedic products. Most of times, new approval products requires submission in proper manner. Read in detail: How to get approval of Ayurvedic products?
4. Approval of formulation is required but approval is granted at basis of ingredients used in it along with reference of any Ayurvedic book bearing information related to each ingredient used in it.
Hope above information is helpful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Excise Duty exemption for Pharma Companies

Query:


We are small scale pharmaceutical manufacturing (formulations) company situated in rural area in Punjab. Please clarify the following with specific notifications
1) Turnover (sale upto 150 lakhs) for the purpose of excise to be calculated on 65% of MRP or based on actual billing price as per invoices.
2) VAT to be charged on 65% of MRP or actual billing price.
Your clarification on the above subject will highly appreciated.

Response:

For turnover upto 150 lakh, there is no excise applicable. Excise is applicable above 150 lakh turnover at manufacturing unit.
1. Excise is applicable to 65% of MRP and calculated as per this.
2. Vat is calculated at actual billing invoice value plus excise duty.

For example:

Your Invoice Value is 40/-
Invoice value as per MRP is 100/-
Excise will be applicable at 65% of mrp i.e. 65/- (Suppose excise duty is 6%) then excise duty will be 65*6%=3.9/-

Now calculate it as per bill:

Amount: 40/-
Excise: 3.9/-
Sub total= 43.9/-
Vat (5%)= 2.20/-
Total value: 46.01/-
Add if any cess, edu cess and other cess or taxes if applicable in it..

Query: 
Thank you for your reply, but my first question is still unanswered, I am again writing the question.
For calculation of sale (turnover) of 150 lakh upto which excise is exempt which of following is correct
1) Sale as per Invoice or
2) 65 % of MRP of sold products
also specify notification regarding the above which ever is applicable.

Response:


Excise of 65% of Mrp is exempted. you can bill at vat (like 5% or 5.25% or which is applicable) on sale as per actual invoice value. You don’t need to add excise mentioned or issue bill under excise in 2) column (65 % of MRP of sold products).

Your Billing will be like:
suppose vat is 5%

Amount: 40/-
Vat (5%)= 2/-
Total value: 42/-


Notification read by clicking here

First it was 1 crore and again it was increased to 1.5 crore 

Hope above information is helpful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Does Small quantity require Ayurvedic manufacturing license?

Query:
If I want to manufacture Ayurvedic product according to Ayurvedic doctor for dispense purpose only, not for sale. Does it require manufacturing license ? Please guide me.
Response:

An Ayurvedic doctor has permission to manufacture Ayurvedic product as per his need, not for sale without any manufacturing license. If you are doctor or your doctor allow you to manufacture small quantity as per his need on the basis of him then you will not need any Ayurvedic manufacturing license.

More Query by Another Reader:

Query:
My father is an Ayurvedic practitioner and we have our own made confidential herbal medicines to treat serious illness. I want to promote these confidential medicines at large scale. My questions are..
Do we need manufacturing license to give medicine to our patients ? or to make distributors and supply them from the beginning?
Response:

For prescribing for your patients, you don’t need any manufacturing license because Ayurvedic Practitioners are allowed to compound some Ayurvedic preparation for their patients use. But if you want to supply that to distributors and other way, you want to promote or sell it, you will require manufacturing license from beginning. You Father has only allow to make these formula for exclusive use of his patients only.
Query:
I need few more information
1. My father is authorize to do practice in one state. For all India he has to take practice license from other state governments. In this case can he supply medicine to his other state patients sitting in his authorize state?
2. Can He sale self made Ayurvedic Preparation compounds online? If any person / patient by our medicine online, in this case do we need manufacturer licences?
3. Can we authorize other Ayurvedic Practioner in other state to give our medicine to his / our patients, in this case can we supply the medicine to that practitioner without manufacturer licences?
4. I belongs to a traditional Ayurvedic practitioners family and we have some good Ayurvedic preparation compounds from our grand parents which are not available in the market by any Ayurvedic medicine manufacturer. After my father how can we continue to sale these Ayurvedic preparation compounds?
Response:
1. Our meaning for prescribing to patient is that, An Ayurvedic Practitioner only can provide the medicines to his patients irrespective from which state he belongs but who visited to an Ayurvedic Practitioner for treatment or who ask for medicines by consulting to him through any mean (telephonic, electronic etc) with labeling showing For use of that patient only (with Name of Patient at label).
2. you can’t sell self made Ayurvedic medicines online. As we mentioned in previous mail, An Ayurvedic Practitioner can only give its own made ayurvedic medicines to his patient only. You will need Ayurvedic Manufacturing License and GSTIN for selling it online.
3. If other Ayurvedic Practitioners are ready to take your products to give to his patient then you can supply medicine to them but these medicines can’t be commercially sell. Only Ayurvedic Practitioner can give to his patients. Main problem you will face, how you will supply to these practitioners inter state. For inter state transaction of product or service, you will need proper documentation like manufacturing license and GSTIN. Within state, you can supply some nearby practitioners for their self use.
4. For preventing your Ayurvedic culture, You should go to take Ayurvedic Manufacturing License and manufacture these formulations under proper documentations.

Hope above information is useful to you..
for any query and suggestion, mail us at pharmafranchiseehelp@gmail.com